Evaluation process

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Dossier evaluation

REACH requires EU companies manufacturing and importing chemicals to assess their chemicals and propose risk management measures. This assessment needs to be documented in a registration dossier which companies need to prepare and submit to ECHA. Information on properties and uses must be provided on all chemicals manufactured or imported in quantities of one tonne or more per year.

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Dossier evaluation covers two processes:

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Compliance check

Compliance checks verify that the submitted information fulfils the legal requirements under REACH. The requirements depend on the quantity of the substance that is manufactured or imported.

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Possible outcomes of the compliance check

You can check the status of the evaluation of a dossier and see the adopted decisions on ECHA’s website.

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Examination of testing proposals

Registrants must submit a testing proposal if they intend to perform a new test listed in Annexes IX and X to REACH.

The aim of testing proposal examination is mainly to avoid unnecessary animal testing, especially when the testing involves the use of vertebrate animals. Registrants need to receive ECHA’s decision before they can perform any testing.

ECHA evaluates all testing proposals made by registrants.

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ECHA prepares its draft decision based on the testing proposal made by the registrant and the information provided by third parties.

Possible outcomes of the testing proposal examination

ECHA addresses all third-party contributions in the dossier evaluation decisions.

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Substance evaluation

The aim of substance evaluation is to clarify whether the use of a substance may cause harm to human health or to the environment. ECHA and the Member States authorities identify such substances of concern.

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Possible outcomes:

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